Take a look at MNKD's chart. That "crack in the ice sheet" on the chart occurred right before ADCOM.
Same thing happened with MNKD. Look at their chart... see that big crack in the ice, so to speak. That was the dive right before ADCOM.
Look at the ADCOM panel briefing docs for MNKD's Afrezza. They were frightening and the ADCOM panel looked hopeless at the start of the day. However, MNKD and the panel turned it around by the end of the day and there was only one vote against approval on two indications.
Jobs posted for a small biotech that IS going it alone: MACK vs MNKD.
You'll see MACK is posting job openings to build a sales staff for MM-398 and they haven't even filed for FDA approval yet (although that will be an accelerated approval).
MNKD has no jobs posted relating to a sales force. MNKD mgmt appears to "more than think" that a partner can be found IMHO.
I own both MACK and MNKD.
I think you're seeing open interest after today. I checked a few days ago and could have sworn open interest at 9 was in the four figures. I think a lot of calls were covered and closed out today.
Actually his returns aren't that much lower than most hedge funds are expecting to return this year (2014). Hedge funds are having a horrible year (see CNBC article 7/21).
Looks like a lot of the $9 calls got closed out today, so at least from the options perspective, there's little reason to take it lower.
200 day moving average is about 6.60 or so. If the pattern continues, the price should retrace at or slightly above it, before the next leg down. I'm not a chart reader, but IMHO the bear price trend reverses on a closing price over 7.20.
The hedge fund could have been a major writer of naked calls that expire tomorrow at strike 9. It is in their interest to ensure those calls expire worthless. There was a bunch of them at strikes 10 and 9. I figured the price would be kept below 10, but I didn't think 9 was in play. That took a prediction of a $1 target price to get it below 9... just one possibility.
The video is available to view on "top documentary films" web site. I only wish they were farther along in clinical trials. It's on my watch list of "safe" biotech investments.
MJ is for nausea in general .. not just for cancer. If you get a bad flu, try using an inhaler with some MJ and you'll be amazed how that nauseous feeling is immediately relieved.
That target was posted before the acquisition that brought in the melanoma treatment... so IMHO it's for AMR-001 only.
Already been done with contact lens.
Here goes for the fifth time since yesterday.. YAHOO keeps deleting my posts. Yes, I noticed I should have used resumed instead of restarted. The 90 day clock starts after the submission is accepted. FDA web sites states it normally takes 15 days for the initial review before the 90 day clock starts. I think the FDA overshot the 15 day review period... but we don't know because Venaxis never told us when the submission was accepted. Right now there's a lot of uncertainty here, that Venaxis needs to clarify if they want investors to return to the stock.
IMHO when the FDA accepted the original submission, they conceded the results were good enough for approval (I was wondering about the specificity). Perhaps Venaxis may need to provide some AI on the device (APPYReader), but given it's already approved in Europe (2013), that gives me hope the device requires no re-design. I can't see any reason to require another human trial unless APPYReader is deficient in some way.
MNKD totally messed up their second FDA submission due to the inhaler. The inhaler was designed to be cleaned and re-used indefinitely. However, the trials showed there were problems with that process, so MNKD tried to switch to their smaller, disposable inhaler in the middle of the trial. FDA issued a CRL for that ... and cost MNKD another $100M +.
DSCO resubmitted around five times due to drug manufacturing facilities... and they still had problems after that during the rollout.
Note the ball is mostly in APPY's court. They have 180 days to respond and if all is in order, the 90 day review clock restarts. Hopefully they will work with the FDA to get it right the first time around. There are consulting firms that specialize in managing the entire process. MNKD used one to help them through the process. I wonder if APPY did?
From the FDA web site:
A. Response to an AI Request
A response to an FDA AI request is the submission of additional information, addressing all of the deficiencies identified in that AI request, that allows FDA to continue or complete the substantive review and reach a decision on the 510(k) submission.
The submitter should provide a complete response to an AI request from FDA. The response should address all of the deficiencies identified by FDA in its AI request.
The submitter’s submission of a response to an AI request is an action that, upon receipt by FDA, resumes the FDA review clock, i.e., the 90-day review clock resumes upon receipt of the additional information.
Note: If FDA determines that the submitter has not addressed one or more of the deficiencies identified in the AI request, the review cycle will be terminated until FDA receives a response addressing the remaining deficiencies. In such a case, FDA intends to inform the submitter by telephone, fax, or e-mail that the response is incomplete and, therefore, the review clock has not resumed. In such a case, the 510(k) will be placed back on hold as of the date of the AI request, and the submitter will have 180 days from the date of the AI request in which to submit a complete response, or the 510(k) will be considered to be withdrawn.
If the submitter submits unsolicited additional information that constitutes a new indication for use or a new technology, because this information would essentially require FDA to restart the substantive review, the submitter will be required to submit a new 510(k) and the associated fee.
Thanks for the info. The first biotech that I was in that did a RS was CMSI. It is still around under a different name: BLFS. I sold C before they did their RS.
This sounds like ZLCS where mgmt had a RS ready if needed, but never did it. I wonder if DVAX mgmt wants to have rights to enact a RS if the price slips below $1?
I'm currently in MNKD, MACK, NBS, APPY (took a wild ride today). Have made a good $$$ in MNKD and MACK. NBS is a long shot and is only a phase II trial, but BAX has a similar phase III going in parallel and NBS is working with BAX on that trial.
APPY got its first set of questions back from the FDA on their submission and looks like shorts pounced on it thinking it was an outright rejection.
I'm also in LVL, DWX, SDIV, KBWD, CEFL, DVHL, LMLP and cash.
Most of the ones I've seen do a reverse were pretty much forced to in order to stay listed. A couple stated the reason was to exceed the magic $5 threshold to attract additional institutional investors. If timed with a positive catalyst an RS seems to have no detrimental price effect and could possibly attract some new investors.
I was in Citibank when they announced their RS, so I promptly sold it. Glad I did because the RS resulted in a pretty significant price drop